Parkinson Disease
Conditions
Brief summary
Our study aims to compare the effects of a standard care plan to one using adapted physical activity in patients with Parkinson Disease. Using actigraphy as an evaluation measure will allow the collection of quantitative and objective data related to activity in contrast to questionnaires which are more subjective and dependent on self-representation. In addition, the evaluation of the caregiver's actigraphy and hardship (Zarit scale) will provide interesting data from this population.
Interventions
OTHERPersonalized activity program
Targeted physical activity
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
The medical team assessing patient functional capacities and caregiver burden at 3 and 6 months will not know which treatment the patient received
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* The patient and their carer have given their free and informed consent and signed the consent form * The patient must be insured of the beneficiary of an insurance policy * The patient is available for the 6 month follow-up * The patient is between 40 and 80 years old * The patient has experienced symptoms of Parkinson Disease for at least 5 years and is in a stable state (no medical event or change of treatment in at least 1 month) * The functional impact and duration of fluctuations is ≥3 (MDS UPDRS) * The patient can walk autonomously, including using a technical aid * The patient does not have any regular physical activity excluding physiotherapy sessions * The patient has daily help from a caregiver
Exclusion criteria
* The subject and/or their caregiver is participating in another study * The subject and/or their caregiver is in a period of exclusion determined by a previous study * The patients is under judicial protection or state guardianship * It proves impossible to give the patient and/or the caregiver clear information * The patients and/or the caregiver reuses to sign the consent form * The patient is pregnant or breast feeding * The patient has anxiety or depression (Score HAD≥ 11/14), cardiac or respiratory failure (stress test), vesico-sphincter problems preventing normal practice of a physical activity, a contraindication to adapted physical activities * The patient cannot walk * Muscular tremor preventing the actigraphy measurement. Outside normal range values for UPDRS measures of: 3.15) postural tremor of the hands; 3.16) action tremor of the hands; 3.17) amplitude of rest tremor
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the impact of an adapted physical activity (APA) program versus standard care on the activity of patients with Parkinson Disease | 3 months | previous weeks' activity measured by actigraphy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life of patients undertaking APA verses standard care | 3 months | Assessed by PDG-39 questionnaire |
| Risk of fall of patients undertaking APA verses standard care | 3 months | measured by Timed Up and Go test |
| Endurance and speed of walking of patients undertaking APA verses standard care | 3 months | 6 minute walk test |
| Activity of the care giver | 3 months | previous weeks' activity measured by actigraphy |
| Activity of patients in both groups | 6 months | previous weeks' activity measured by actigraphy |
| Grip strength | Day 0 | Pinch test |
| Patient dependence | Day 0 | Activities of Daily Living |
| Level of dementia at Day | Day 0 | Instrumental Activities of Daily Living |
| Evaluation of the care burden of care giver | 3 months | Zarit scale |
Countries
France
Outcome results
None listed